# K201343: Triathlon Total KneeSystem

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Jul 10, 2020 after 51 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K941847 (1994). 252 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 255 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 4.
- K190402: Triathlon Total Knee System-Additional Components, Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) (2019) Summary page 4.
- K172524: Zimmer Persona Personalized Knee System, Zimmer, Inc. (2018) Summary page 4.
- K173890: GMK Sphere - Kinematic Alignment, Medacta International S.A. (2018) Summary page 4.

## Most influential descendants
- K221850: GMK 3D Metal Tibial Tray (2022), 1 descendant of its own
- K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (2026), 0 descendants of its own
- K253328: GMK 3D Metal Tibial Tray Extension (2026), 0 descendants of its own

## Indications for use
General Total Knee Arthroplasty (TKR) Indications: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. • Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. • Revision of previous unsuccessful knee replacement or other procedure. • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques. The Triathlon Tritanium Tibial Baseplate and Tritanium Metal-Backed Patella components are indicated for both uncemented and cemented use. The Triathlon Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only. The Triathlon All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (PS) Components: • Ligamentous instability requiring implant bearing surface geometries with increased constraint. • Absent or non-functioning posterior cruciate ligament. • Severe anteroposterior instability of the knee joint.

Source page: https://510kreport.com/device/K201343
Methodology: https://510kreport.com/methodology